Senior Medical Writer - Remote
Lifelancer
Date: 5 hours ago
City: Remote, Remote
Contract type: Full time
Remote
Responsibilities:
Please use the below Lifelancer link for job application and quicker response.
https://lifelancer.com/jobs/view/8e908a8f93f58bd9d74aa2d21cc363de
- Produce well-written, high-quality, timely Medical Writing documents (like Clinical Study Reports, Protocols and amendments, Investigator's Brochure [IB] and IB updates, etc)
- Review (including peer and QC review) Medical Writing documents in accordance with current SOPs, ensuring checklists and tracking documents are completed
- Proof-read and provide editorial support on documents produced by other departments in company or by clients, if requested
- Provide oversight on Medical Writing projects and/or cross-functional projects using project management tools and processes
- Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and adequately addressed
- Assist Principal Medical Writers and above with the management of department budget and financials
- Actively contribute to business development by keeping CV up-to-date, preparing and reviewing client proposals and other business development documentation, as well as presenting at client meetings and bid defense meetings
- Line manage assigned personnel taking an active role in their development and provide guidance and mentorship to less experienced Medical Writers
- Conduct literature reviews and provide input on the development of scientific communication and messaging
- Manage timelines and deliver documents within established deadlines
- Master's degree or higher in a life science or related field.
- Minimum 5 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
- Strong knowledge of clinical research, regulatory requirements, and industry guidelines (ICH-GCP).
- Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific information effectively.
- Experience in writing clinical study documents, such as protocols, clinical study reports, and regulatory submission documents.
- Detail-oriented with excellent organizational and time management skills.
- Ability to work independently and collaboratively in a team environment.
Please use the below Lifelancer link for job application and quicker response.
https://lifelancer.com/jobs/view/8e908a8f93f58bd9d74aa2d21cc363de
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